Device and Method for Treating Osteonecrosis

ABSTRACT

The present invention includes a method and devices for treating osteonecrosis in, e.g., children, adolescents, and adults comprising: identifying a subject in need of treatment for osteonecrosis; drilling two or more holes into a bone in need of treatment for osteonecrosis; inserting two or more needles or cannulas into the holes in the bone; washing an interior of the bone with a washing fluid introduced through one or more of the needles or cannulas inserted into the bone; and after washing the interior of the bone introducing one or more bone growth promoting materials or cells into the bone.

CROSS-REFERENCE TO RELATED APPLICATIONS

None.

STATEMENT OF FEDERALLY FUNDED RESEARCH

None.

TECHNICAL FIELD OF THE INVENTION

The present invention relates in general to the field of osteonecrosis,and more particularly, to a novel device and method for treatingosteonecrosis, such as, Legg-Calve-Perthes disease.

BACKGROUND OF THE INVENTION

Without limiting the scope of the invention, its background is describedin connection with tissue regeneration.

One such method is taught in U.S. Pat. No. 9,138,317, issued to McGee,entitled “Conduits for enhancing tissue regeneration”, which is said toteach apparatuses, systems, and methods for enhancing bone or softtissue regeneration. For example, a conduit, having one or moresegments, can originate at a tissue regeneration site and can have afirst opening to promote physiological signals to enter the conduit andtransit to a second opening that penetrates a histologically rich sourceof multipotent mesenchymal cells, promoting the multipotent mesenchymalcells to produce tissue regeneration response products, the responseproducts transiting through the second opening to egress at the firstopening of the conduit, and promoting tissue regeneration at the tissueregeneration site.

Another such method is taught in U.S. Pat. No. 8,382,762, issued toBrannon, entitled “Endoscopic bone debridement”, which is said to teachan osteoendoscopic cylinder for tamponading bleeding along alongitudinal canal surface of an osteocentral canal of a femoral neck soas to allow endoscopic visualization of a segment of osteonecrotic bonewithin a femoral head. The osteoendoscopic cylinder is of a dimensionadapted to receive an endoscope therein and includes an inner visualsurface and an outer bony contact surface. An orientation mark along theinner visual surface is of a size and dimension to ensure a firstvisualization thereof with the endoscope.

SUMMARY OF THE INVENTION

In one embodiment, the present invention includes a method of treatingosteonecrosis comprising: identifying a subject in need of treatment forosteonecrosis; drilling two or more holes into a bone in need oftreatment for osteonecrosis; inserting two or more needles or cannulasinto the holes in the bone; washing an interior of the bone with awashing fluid introduced through one or more of the needles or cannulasinserted into the bone; and after washing the interior of the boneintroducing one or more bone growth promoting materials into the bone.In one aspect, the washing fluid is a biocompatible isotonic fluid andoptionally comprises biocompatible detergents, biocompatiblesurfactants, biocompatible alcohols, antibiotics, preservatives, orcombinations thereof. In another aspect, the method further comprisesinjecting the washed bone with at least one of autologous bone marrow,autologous bone stem cells, bone growth material, bone graft material,bone void filler, cancellous bone graft or fragments, hydrogels,gelatins, osteoconductive material, osteoproliferative material,osteoinductive material, a bone morphogenic cytokine, bone morphogenicprotein, a bone morphogenic protein-2 (BMP-2), bone material infusedcollagen matrix, or bone morphogenic protein infused collagen matrix. Inanother aspect, the method further comprises washing the interior of thebone until the washing fluid is clear. In another aspect, the bone is afemoral head, a humeral head, a knee condyle, or an ankle talus. Inanother aspect, the washing fluid cleans at least 50, 60, 70, 75, 80,85, or 90% of the volume within the bone. In another aspect, the methodfurther comprises measuring the amount of cell debris and fat in thewashing fluid and washing until the amount of cell debris and fat in thewashing fluid is minimized. In another aspect, the method furthercomprises injecting the washing fluid through a first needle or cannulaand drawing the washing fluid out of a second needle or cannula. Inanother aspect, the surgical instrument further comprises washing fluidis introduced and drawn with a syringe attached to the needle orcannula.

In another embodiment, the present invention includes a method oftreating Legg-Calvé-Perthes Disease comprising: identifying a subject inneed of treatment for Legg-Calvé-Perthes Disease; drilling two or moreholes into a femoral head; inserting two or more needles or cannulasinto the femoral head; washing an interior of the femoral head with awashing fluid introduced through one or more of the needles or cannulasdrilled into the femoral head; and after washing the interior of thefemoral head introducing a bone growth promoting material into thefemoral head. In one aspect, the method further comprises washing fluidis a biocompatible isotonic fluid and optionally comprises biocompatibledetergents, biocompatible surfactants, biocompatible alcohols,antibiotics, preservatives, or combinations thereof. In another aspect,the subject is a pediatric, an adolescent, or an adult. In anotheraspect, the femoral head osteonecrosis is idiopathic (unknown cause) ordue to corticosteroid, trauma, alcohol, sickle cell disease, or otherknown causes of osteonecrosis. In another aspect, the method furthercomprises injecting the washed bone with at least one of autologous bonemarrow, autologous bone stem cells, bone growth material, bone graftmaterial, bone void filler, cancellous bone graft or fragments,hydrogels, gelatins, osteoconductive material, osteoproliferativematerial, osteoinductive material, a bone morphogenic cytokine, bonemorphogenic protein, a bone morphogenic protein-2 (BMP-2), bone materialinfused collagen matrix, or bone morphogenic protein infused collagenmatrix. In another aspect, the method further comprises washing theinterior of the femoral head until the washing fluid is clear beforeinjecting the bone growth promoting material into the femoral head. Inanother aspect, the washing fluid cleans at least 50, 60, 70, 75, 80,85, or 90% of the volume within the femoral head. In another aspect, themethod further comprises measuring the amount of cell debris and fat inthe washing fluid and washing until the amount of cell debris and fat inthe washing fluid is minimized. In another aspect, the method furthercomprises washing fluid through a first needle or cannula and drawingthe washing fluid out of a second needle or cannula. In another aspect,the washing fluid is introduced into the femoral head and drawn from thefemoral head with a syringe attached to the needle or cannula.

Yet another embodiment of the present invention includes a surgicalinstrument comprising: a first and a second drill bit capable ofdrilling into a femoral head, a humeral head, a knee condyle, or anankle talus, wherein the first and second drills create adjacent holesin the femoral head, the humeral head, the knee condyle, or the ankletalus; one or more motors attached to and capable of rotating the firstand second drill bits; a handle to control the direction of the firstand second drill bits; and an on/off switch connected to the motor. Inone aspect, at least one of the drill bits is defined further as aneedle or cannula. In another aspect, the one or more motors areelectrical, mechanical, pneumatic, hydraulic, or combinations thereof.In another aspect, the surgical instrument further comprises one or moregears between the one or more motors and the two or more drills that atleast one of: increase or decrease the speed of the two or more drills,or increase or decrease the torque of the two or more drills. In anotheraspect, the apparatus further comprises one or more drill chucks capableof holding drills of different sizes. In another aspect, the on/offswitch is a variable speed switch. In another aspect, the apparatusfurther comprises a cam that provides a hammer action, a rotary action,or both a rotary and hammer action, to the two or more drill bits. Inanother aspect, the drill bits or the apparatus is disposable. Inanother aspect, the subject is a pediatric, an adolescent, or an adult.In another aspect, the femoral head osteonecrosis is idiopathic (unknowncause) or due to corticosteroid, trauma, alcohol, sickle cell disease,or other known causes of osteonecrosis. In another aspect, the surgicalinstrument further comprises a drill press mechanism at least one of:increases the control by a user, increases a leverage of a user, or isadjustable to increase or decrease an angle between the two or moredrill bits to compensate for the size of the femoral head, wherein thedrill press is angled to direct the two or more drill bits into a regionat or below the greater trochanter or humerus metaphysis, through a neckof the femur or humerus, and into the femoral or humeral head. Inanother aspect, the surgical instrument further comprises one or moresleeves or tubes surrounding the two or more drill bits, wherein thesleeves are adapted to remain after the drills have been removed fromthe femoral head to at least one of: facilitate the washing of thefemoral head, or introduce bone growth promoting agents into the femoralhead. In another aspect, the one or more drill bits are internallycooled. In another aspect, the one or more drill bits comprise a slowspiral, a standard spiral, a quick spiral, a worm spiral, two or moreflutings, a split point, or a step tip. In another aspect, the surgicalinstrument further comprises a drill guide that controls the directionof the two or more drill bits, wherein the drill guide is adapted to beaffixed to a skin adjacent the femoral head, wherein openings in thedrill guide are aligned with a greater trochanter, a neck of the femur,and the femoral head.

In yet another embodiment, the present invention includes a drill guidethat controls the direction of the two or more drill bits, comprising:two or openings in the drill guide are aligned with a greatertrochanter, a neck of the femur, and the femoral head; and a skinattachment mechanism, wherein the skin attachment mechanism affixes, atleast temporarily, the drill guide in communication with the greatertrochanter, the neck of the femur, and the femoral head. In one aspect,the skin attachment mechanism is an adhesive, a pin or pins, and/or oneor more suction cups. In another aspect, the skin attachment mechanismis an arm of an apparatus controllable in an x-y, a y-z, an x-z, or anx-y-z axis.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the features and advantages of thepresent invention, reference is now made to the detailed description ofthe invention along with the accompanying figures and in which:

FIGS. 1A and 1B show a photograph (FIG. 1A) and a matching radiograph(FIG. 1B) of a humeral head into which two needles or cannulas areinserted of the present invention.

FIG. 2 shows a femoral head into which two needles or cannulas areinserted and are connected to syringes, the top syringe having a clearwashing fluid, and the bottom syringe showing cell debris and fat in thewashing fluid after traversing the femoral head.

FIG. 3A shows on the left an unwashed femoral head, and the right awashed femoral head using the present invention.

FIG. 3B shows a cross-section of an unwashed femoral head.

FIG. 3C shows a cross-section of a femoral head washed according to thepresent invention.

FIG. 4 shows a progression of washes of the femoral head shows in FIG.3C and on the right the initial saline.

FIG. 5A and 5B show a low and a high magnification, respectively, of thewash solution after cyto-spin to demonstrate that the solution containscell debris from the femoral head.

FIG. 6A and 6B each show the histology at a low (4x) and a high (10x)magnification of the unwashed femoral head (FIG. 6A) and the washedfemoral head (FIG. 6B) according to the present invention.

FIGS. 7A to 7C show the histology of the femoral head without (FIG. 7A),with a saline wash (FIG. 7B) and with an ethanol and saline wash (FIG.7C) to remove fat and cell debris.

FIG. 8A shows a single needle of the prior art (left, radiograph), andthe distribution of an imaging agent injected into the femoral head(right) through the single opening.

FIG. 8B shows a multiple needle (left, radiograph), wash, and injectionof the distribution of an agent injected into the femoral head (right)using a four opening method in which one or two needles or cannulas areused to wash and two or three needles used to remove the wash and,likewise, the delivery the imaging agent using the present invention.

FIG. 9 is a graph that compares the prior art with a 4 needle/cannulamethod, and the 4 needle/cannula method that also included the wash, andthe distribution of the imaging agent in the femoral head.

FIGS. 10A to 10C shows the histology of the femoral head of a normalfemoral head (FIG. 10A), after multiple drilling only (FIG. 10B) andmultiple drilling and saline wash (FIG. 10C), wherein bone washingimproved bone healing, showed decreases resorption and increased boneformation.

FIG. 11A shows micro-computer tomography (Micro-CT) and histologicassessments comparing a normal femoral head, a femoral head treated withthe non-weight bearing method of the prior art, the non-weight bearingand multiple drilling of the prior art, non-weight bearing+multipledrilling+saline wash of the present invention, and non-weightbearing+multiple drilling+saline wash+BMP2/gelatin injection of thepresent invention.

FIG. 11B is a graph that compares a percent bone volume of a normalfemoral head, a femoral head treated with the non-weight bearing methodof the prior art, the non-weight bearing and multiple drilling of theprior art, non-weight bearing+multiple drilling+saline wash of thepresent invention, and non-weight bearing+multiple drilling+salinewash+BMP2/gelatin injection of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

While the making and using of various embodiments of the presentinvention are discussed in detail below, it should be appreciated thatthe present invention provides many applicable inventive concepts thatcan be embodied in a wide variety of specific contexts. The specificembodiments discussed herein are merely illustrative of specific ways tomake and use the invention and do not delimit the scope of theinvention.

To facilitate the understanding of this invention, a number of terms aredefined below. Terms defined herein have meanings as commonly understoodby a person of ordinary skill in the areas relevant to the presentinvention. Terms such as “a”, “an” and “the” are not intended to referto only a singular entity, but include the general class of which aspecific example may be used for illustration. The terminology herein isused to describe specific embodiments of the invention, but their usagedoes not limit the invention, except as outlined in the claims.

New Necrotic Bone Washing Technique.

The bone washing technique of the present invention involves placementof two or more intra-osseous needles or cannulas into pediatric or adultfemoral heads for treatment of avascular necrosis (AVN) orosteonecrosis. This technique permits inflow and outflow of washingsolution through the needle(s) or cannula(s) to remove, e.g., dead celldebris, necrotic marrow fat, and/or inflammatory factors. It isdemonstrated herein that the removal of dead cell debris, necroticmarrow fat, and/or inflammatory factors from the marrow spacesignificantly improves bone healing and creates space for the injectionor infusion of biological therapeutic agents and/or stem cells.

Briefly, two or more intra-osseous needles and/or cannulas are placed5-15 mm apart depending on the necrotic bone volume and the size of thefemoral head. Either trans-articular (through the joint and articularcartilage) or trans-physeal/metaphyseal (starting from region below thegreater trochanter) or combination needle placement technique can beused. The needles are most often inserted under fluoroscopic guidanceand a specialized needle placement device may be used to facilitate theplacement of the needles. The present invention can be used in a widevariety of locations that includes osteonecrosis, e.g., the femoralhead, the humeral head, the knee condyle, or the ankle talus.

After the placement of two or more intra-osseous needles and/or cannulaswithin the necrotic bone, aspiration (negative pressure),injection/infusion (positive pressure), and/or a combination of both,are used to provide a high volume of washing solution to flow throughthe necrotic femoral head to remove the dead cell debris. A high volumewashing of the necrotic bone can be facilitated by using a mechanicaldevice or a pump. The amount of volume required for washing or thetermination of the washing technique can be determined by assessing theclarity/turbidity of the outflow solution. Further assessment of theoutflow solution can be done by measuring levels of specificinflammatory factors using visual, qualitative and/or quantitativeassays.

The needles and/or cannulas will generally have followingspecifications: (1) 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, or 6-15 gauge indiameter, depending on the size of the femoral head and the bonenecrosis; (2) the tip of the needle should be less than 1.5 mm long toavoid unintentional penetration through the femoral head, but can be 8,9, 10, 12, 15, 20, 25, 30 or more centimeters, e.g., 10 to 30 cm; and/or(3) the needle may have one or more fenestrations near the tip toincrease the distribution and collection of bone washing solution.

A wide variety of washing solutions and combinations of solutions arecontemplated for use with the present invention. The washing solutioncan be based on saline, various concentrations of ethanol, and/orinclude one or more biocompatible detergent and/or surfactants forremoving/extracting cell debris, necrotic fat, or the necroticextracellular matrix. The washing solution may also include antibioticsor other antimicrobial agents. The washing solution may also contain oneor more bioactive agents, enzymes, or nanoparticles that facilitate theremoval of the necrotic fat and the extracellular matrix in the necroticbone marrow. The washing solution may also contain drugs or agents thatstimulate angiogenesis (for instance by activation of hypoxia induciblefactor-1 and vascular endothelial growth factor pathways) or stimulateosteogenesis (for instance through Wnt and/or BMP signaling pathways).

Generally, the temperature of wash solution should be warmed up to thebody temperature to be physiological and more effective in removing celldebris.

EXAMPLE 2 New Stem Cell or Bone Active Agent Delivery Technique

The bone delivery technique involves placement of two or moreintra-osseous needles and/or cannulas into pediatric or adult femoralheads for treatment of avascular necrosis (AVN) or osteonecrosis. Thistechnique can be used with or without first performing the bone washingtechnique outlined above. The use of two or more intra-osseous deliveryneedles and/or cannulas improves the local distribution of stem cells orbone active agents in the necrotic femoral head by subdividing the totalvolume of cells or bone active agents to be injected into multiplesites. The technique also improves the local retention of stem cells orbone active agents by decreasing the backflow pressure, unlike thesingle needle delivery technique where the total volume of injectant isdelivered through a single needle site.

This technique can be used to inject cells or bone active agents aloneor in combination with a delivery/carrier agent such as hydrogel orgelatin, which can be chemically designed to improve the retention ofstem cells and growth factors such as bone morphogenetic proteins(BMPs).

The use of two or more needles and/or cannulas also permits two-steppreparation of the necrotic bone for the delivery of stem cells or boneactive agents. In the first step, a bone washing and preparationsolution will be used to remove the cell debris and to distribute achemical or catalyst required for a chemical reaction which will improvethe local retention of a delivery agent and a growth factor when theyare injected or infused in the second step.

The needle and/or cannulas specification are same as that for the bonewashing technique described above.

FIGS. 1A and 1B show a photograph (FIG. 1A) and a matching radiograph(FIG. 1B) of a humeral head into which two needles (Vidacare, SanAntonio, Tex.) or cannulas are inserted of the present invention in amodel pig humeral head. The present invention allows the user to eitherinject and/or aspirate or both (i.e. positive and/or negative pressurewashing), decreases the pressure of injection associated with singleneedle technique, and minimizes leakage. In the prior art using thesingle needle technique it is known that the leakage of bone promotingfactors, such as BMP-2 leads to the formation of bone outside thefemoral head as a result of leakage, which greatly increases themorbidity of the procedure. The present invention eliminates leakage andthe growth of bone outside the femoral head. In particular, a materialthat is sufficiently viscous is injected/aspired that prohibits itsrelease outside the femoral head, and/or plugs (e.g., biodegradableplugs) can be inserted into the openings to prevent leakage.

FIG. 2 shows a femoral head of a pig into which two needles or cannulasare inserted and are connected to syringes, the top syringe having aclear washing fluid, and the bottom syringe showing cell debris and fatin the washing fluid after traversing the femoral head. By washing outnecrotic bone to remove necrotic cell debris and inflammatory factorsthe present invention improve bone healing.

FIG. 3A shows on the left an unwashed femoral head of a pig, and theright a washed femoral head using the present invention. FIG. 3B shows across-section of an unwashed femoral head of a pig. FIG. 3C shows across-section of a femoral head of a pig washed according to the presentinvention. FIG. 4 shows a progression of washes of the femoral head of apig shows in FIG. 3C and on the right the initial saline, whichdemonstrates the removal of dead cell debris, necrotic marrow fat,and/or inflammatory factors.

FIG. 5A and 5B show a low and a high magnification, respectively, of thewash solution after cyto-spin to demonstrate that the solution containscell debris from the femoral head of a pig. The wash solution was shownto contain cell debris that was washed out of the femoral head.

FIG. 6A and 6B each show the histology at a low (4×) and a high (10×)magnification of the unwashed femoral head (FIG. 6A) and the washedfemoral head (FIG. 6B) according to the present invention.

FIGS. 7A to 7C show the histology of the femoral head without (FIG. 7A),with a saline wash (FIG. 7B) and with an ethanol and saline wash (FIG.7C) to remove fat and cell debris. It was found that saline wash removesfat and cell debris, while ethanol further removes fat. Both washsolutions were shown to create space for bone stimulating biomaterialsincluding marrow stem cells.

FIG. 8A shows a single needle of the prior art (left, radiograph), andthe distribution of an imaging agent injected into the femoral head(right) through the single opening. FIG. 8B shows a multiple needle(left, radiograph), wash, and injection of the distribution of an agentinjected into the femoral head (right) using a four opening method inwhich one or two needles or cannulas are used to wash and two or threeneedles used to remove the wash and, likewise, the delivery the imagingagent using the present invention. The images on the right clearly showthat the multiple needle/cannula method provides a much widerdistribution of the visualization agent, while the single injectionshows an umbrella-like distribution.

FIG. 9 is a graph that compares the prior art with a 4 needle/cannulamethod, and the 4 needle/cannula method that also included the wash, andthe distribution of the imaging agent in the femoral head.

FIGS. 10A to 10C show the histology of the femoral head of a normalfemoral head (FIG. 10A), after drilling only (FIG. 10B) and drilling andsaline wash (FIG. 10C), wherein bone washing improved bone healing,showed decreases resorption and increased bone formation. Thus, the bonewashing of the present invention improves bone healing, shows decreasedresorption, and increased bone formation.

FIG. 11A shows a micro-computer tomography (Micro-CT) assessmentcompares a normal femoral head, a femoral head treated with thenon-weight bearing method of the prior art, the non-weight bearing andmultiple drilling of the prior art, and non-weightbearing+drilling,+saline wash of the present invention. FIG. 11B is agraph that compares a percent bone volume of a normal femoral head, afemoral head treated with the non-weight bearing method of the priorart, the non-weight bearing and multiple drilling of the prior art, andnon-weight bearing+multiple drilling,+saline wash of the presentinvention.

In conclusion, the present invention includes: (1) the development of aminimally invasive method to wash out dead cells and necrotic fatmaterials from the marrow to improve bone healing, (2) the ability tolower the pressure of injection and minimize leakage of therapeuticagents, and (3) the ability to increase the distribution of therapeuticagents.

It is contemplated that any embodiment discussed in this specificationcan be implemented with respect to any method, kit, reagent, orcomposition of the invention, and vice versa. Furthermore, compositionsof the invention can be used to achieve methods of the invention.

It will be understood that particular embodiments described herein areshown by way of illustration and not as limitations of the invention.The principal features of this invention can be employed in variousembodiments without departing from the scope of the invention. Thoseskilled in the art will recognize, or be able to ascertain using no morethan routine experimentation, numerous equivalents to the specificprocedures described herein. Such equivalents are considered to bewithin the scope of this invention and are covered by the claims.

All publications and patent applications mentioned in the specificationare indicative of the level of skill of those skilled in the art towhich this invention pertains. All publications and patent applicationsare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

The use of the word “a” or “an” when used in conjunction with the term“comprising” in the claims and/or the specification may mean “one,” butit is also consistent with the meaning of “one or more,” “at least one,”and “one or more than one.” The use of the term “or” in the claims isused to mean “and/or” unless explicitly indicated to refer toalternatives only or the alternatives are mutually exclusive, althoughthe disclosure supports a definition that refers to only alternativesand “and/or.” Throughout this application, the term “about” is used toindicate that a value includes the inherent variation of error for thedevice, the method being employed to determine the value, or thevariation that exists among the study subjects.

As used in this specification and claim(s), the words “comprising” (andany form of comprising, such as “comprise” and “comprises”), “having”(and any form of having, such as “have” and “has”), “including” (and anyform of including, such as “includes” and “include”) or “containing”(and any form of containing, such as “contains” and “contain”) areinclusive or open-ended and do not exclude additional, unrecitedelements or method steps. In embodiments of any of the compositions andmethods provided herein, “comprising” may be replaced with “consistingessentially of” or “consisting of”. As used herein, the phrase“consisting essentially of” requires the specified integer(s) or stepsas well as those that do not materially affect the character or functionof the claimed invention. As used herein, the term “consisting” is usedto indicate the presence of the recited integer (e.g., a feature, anelement, a characteristic, a property, a method/process step or alimitation) or group of integers (e.g., feature(s), element(s),characteristic(s), property(ies), method/process steps or limitation(s))only.

The term “or combinations thereof” as used herein refers to allpermutations and combinations of the listed items preceding the term.For example, “A, B, C, or combinations thereof” is intended to includeat least one of: A, B, C, AB, AC, BC, or ABC, and if order is importantin a particular context, also BA, CA, CB, CBA, BCA, ACB, BAC, or CAB.Continuing with this example, expressly included are combinations thatcontain repeats of one or more item or term, such as BB, AAA, AB, BBC,AAABCCCC, CBBAAA, CABABB, and so forth. The skilled artisan willunderstand that typically there is no limit on the number of items orterms in any combination, unless otherwise apparent from the context.

As used herein, words of approximation such as, without limitation,“about”, “substantial” or “substantially” refers to a condition thatwhen so modified is understood to not necessarily be absolute or perfectbut would be considered close enough to those of ordinary skill in theart to warrant designating the condition as being present. The extent towhich the description may vary will depend on how great a change can beinstituted and still have one of ordinary skilled in the art recognizethe modified feature as still having the required characteristics andcapabilities of the unmodified feature. In general, but subject to thepreceding discussion, a numerical value herein that is modified by aword of approximation such as “about” may vary from the stated value byat least ±1, 2, 3, 4, 5, 6, 7, 10, 12 or 15%.

All of the compositions and/or methods disclosed and claimed herein canbe made and executed without undue experimentation in light of thepresent disclosure. While the compositions and methods of this inventionhave been described in terms of preferred embodiments, it will beapparent to those of skill in the art that variations may be applied tothe compositions and/or methods and in the steps or in the sequence ofsteps of the method described herein without departing from the concept,spirit and scope of the invention. All such similar substitutes andmodifications apparent to those skilled in the art are deemed to bewithin the spirit, scope and concept of the invention as defined by theappended claims.

What is claimed is:
 1. A method of treating an osteonecrosis comprising:identifying a subject in need of treatment for osteonecrosis; drillingtwo or more holes into a bone in need of treatment for osteonecrosis;inserting two or more needles or cannulas into the holes in the bone;washing an interior of the bone with a washing fluid introduced throughone or more of the needles or cannulas inserted into the bone; and afterwashing the interior of the bone introducing one or more bone growthpromoting materials into the bone.
 2. The method of claim 1, wherein thewashing fluid is a biocompatible isotonic fluid and optionally comprisesbiocompatible detergents, biocompatible surfactants, biocompatiblealcohols, antibiotics, preservatives, or combinations thereof.
 3. Themethod of claim 1, further comprising injecting the washed bone with atleast one of autologous bone marrow, autologous bone stem cells, bonegrowth material, bone graft material, bone void filler, cancellous bonegraft or fragments, hydrogels, gelatins, osteoconductive material,osteoproliferative material, osteoinductive material, a bone morphogeniccytokine, bone morphogenic protein, a bone morphogenic protein-2(BMP-2), bone material infused collagen matrix, or bone morphogenicprotein infused collagen matrix.
 4. The method of claim 1, furthercomprising the step of washing the interior of the bone until thewashing fluid is clear.
 5. The method of claim 1, wherein the bone is afemoral head, a humeral head, a knee condyle, or an ankle talus.
 6. Themethod of claim 1, wherein the washing fluid cleans at least 50, 60, 70,75, 80, 85, or 90% of the volume within the bone.
 7. The method of claim1, wherein the subject is a pediatric, an adolescent, or an adult. 8.The method of claim 1, wherein the osteonecrosis is idiopathic (unknowncause), due to corticosteroid, trauma, alcohol, sickle cell disease, orother known causes of osteonecrosis.
 9. The method of claim 1, furthercomprising the step of measuring the amount of cell debris and fat inthe washing fluid and washing until the amount of cell debris and fat inthe washing fluid is minimized.
 10. The method of claim 1, furthercomprising injecting the washing fluid through a first needle or cannulaand drawing the washing fluid out of a second needle or cannula.
 11. Themethod of claim 10, wherein the washing fluid is introduced and drawnwith a syringe attached to the needle or cannula.
 12. A method oftreating Legg-Calvé-Perthes Disease comprising: identifying a subject inneed of treatment for Legg-Calvé-Perthes Disease; drilling two or moreholes into a femoral head; inserting two or more needles or cannulasinto the femoral head; washing an interior of the femoral head with awashing fluid introduced through one or more of the needles or cannulasdrilled into the femoral head; and after washing the interior of thefemoral head introducing a bone growth promoting material into thefemoral head.
 13. The method of claim 1, wherein the washing fluid is abiocompatible isotonic fluid and optionally comprises biocompatibledetergents, biocompatible surfactants, biocompatible alcohols,antibiotics, preservatives, or combinations thereof.
 14. The method ofclaim 1, further comprising injecting the washed bone with at least oneof autologous bone marrow, autologous bone stem cells, bone growthmaterial, bone graft material, bone void filler, cancellous bone graftor fragments, hydrogels, gelatins, osteoconductive material,osteoproliferative material, osteoinductive material, a bone morphogeniccytokine, bone morphogenic protein, a bone morphogenic protein-2(BMP-2), bone material infused collagen matrix, or bone morphogenicprotein infused collagen matrix.
 15. The method of claim 1, furthercomprising the step of washing the interior of the femoral head untilthe washing fluid is clear before injecting the bone growth promotingmaterial into the femoral head.
 16. The method of claim 1, wherein thewashing fluid cleans at least 50, 60, 70, 75, 80, 85, or 90% of thevolume within the femoral head.
 17. The method of claim 1, furthercomprising the step of measuring the amount of cell debris and fat inthe washing fluid and washing until the amount of cell debris and fat inthe washing fluid is minimized.
 18. The method of claim 1, furthercomprising injecting the washing fluid through a first needle or cannulaand drawing the washing fluid out of a second needle or cannula.
 19. Themethod of claim 10, wherein the washing fluid is introduced into thefemoral head and drawn from the femoral head with a syringe attached tothe needle or cannula.
 20. The method of claim 1, wherein the subject isa pediatric, an adolescent, or an adult.
 21. The method of claim 1,wherein the osteonecrosis is idiopathic (unknown cause), due tocorticosteroid, trauma, alcohol, sickle cell disease, or other knowncauses of osteonecrosis..
 22. A surgical instrument comprising: a firstand a second drill bit, needle or cannula, capable of drilling into afemoral head, a humeral head, a knee condyle, or an ankle talus, whereinthe first and second drills create adjacent holes in the femoral head,the humeral head, the knee condyle, or the ankle talus; one or moremotors attached to and capable of rotating the first and second drillbits; a handle to control the direction of the first and second drillbits; and an on/off switch connected to the motor.
 23. The surgicalinstrument of claim 22, wherein at least one of the drill bits isdefined further as a needle or cannula.
 24. The surgical instrument ofclaim 23, wherein the needle or cannula with an opening on the tip orside of the needle or cannula increase distribution and collection of awashing fluid or increase distribution of one or more injectants such asstem cells and bioactive materials and proteins.
 25. The surgicalinstrument of claim 22, wherein the one or more motors are electrical,mechanical, pneumatic, hydraulic, or combinations thereof.
 26. Thesurgical instrument of claim 22, further comprising one or more gearsbetween the one or more motors and the two or more drills that at leastone of: increase or decrease the speed of the two or more drills, orincrease or decrease the torque of the two or more drills.
 27. Thesurgical instrument of claim 22, wherein the apparatus further comprisesone or more drill chucks capable of holding drills of different sizes.28. The surgical instrument of claim 22, wherein the on/off switch is avariable speed switch.
 29. The surgical instrument of claim 22, whereinthe apparatus further comprises a cam that provides a hammer action, arotary action, or both a rotary and hammer action, to the two or moredrill bits.
 30. The surgical instrument of claim 22, wherein the drillbits or the apparatus is disposable.
 31. The surgical instrument ofclaim 22, further comprising a drill press mechanism at least one of:increases the control by a user, increases a leverage of a user, or isadjustable to increase or decrease an angle between the two or moredrill bits to compensate for the size of the femoral head, wherein thedrill press is angled to direct the two or more drill bits into a regionat or below the greater trochanter or humerus metaphysis, through a neckof the femur or humerus, and into the femoral or humeral head.
 32. Thesurgical instrument of claim 22, further comprising one or more sleevesor tubes surrounding the two or more drill bits, wherein the sleeves areadapted to remain after the drills have been removed from the femoralhead to at least one of: facilitate the washing of the femoral head, orintroduce bone growth promoting agents into the femoral head.
 33. Thesurgical instrument of claim 22, wherein the one or more drill bits areinternally cooled.
 34. The surgical instrument of claim 22, wherein theone or more drill bits comprise a slow spiral, a standard spiral, aquick spiral, a worm spiral, two or more flutings, a split point, or astep tip.
 35. The surgical instrument of claim 22, further comprising adrill guide that controls the direction of the two or more drill bits,wherein the drill guide is adapted to be affixed to a skin adjacent thefemoral head, wherein openings in the drill guide are aligned with agreater trochanter, a neck of the femur, and the femoral head.
 36. Adrill guide that controls the direction of the two or more drill bits,comprising: two or more openings in the drill guide are aligned with agreater trochanter, a neck of the femur, and the femoral head and areadapted to receive a drill bit, needle, or cannula; and a skinattachment mechanism, wherein the skin attachment mechanism affixes, atleast temporarily, the drill guide in communication with a femoral head,a humeral head, a knee condyle, or an ankle talus.
 37. The drill guideof claim 36, wherein the skin attachment mechanism is an adhesive, a pinor pins, or one or more suction cups.
 38. The drill guide of claim 36,wherein the skin attachment mechanism is an arm of an apparatuscontrollable in an x-y, a y-z, an x-z, or an x-y-z axis.